Syllabus
GMP Deviations, CAPA, and Inspection Readiness Professional Certificate
36 lessons, about 12 hours. Online and self-paced, with a certificate when you finish.
GMP Regulatory Foundations
Establish the regulatory framework, quality-unit responsibilities, pharmaceutical quality-system expectations, and documentation requirements governing GMP investigations.
- 1GMP Regulatory Frameworks and Product Scope
- 2Quality Unit Authority and Decision Rights
- 3Pharmaceutical Quality System Governance
- 4GMP Documentation and Electronic Records
Deviation Management
Develop the ability to recognize, classify, document, contain, escalate, and assess GMP deviations using scientifically justified product-impact decisions.
- 5Deviation Recognition and Classification
- 6Event Notification and Initial Containment
- 7Deviation Narratives and Event Chronology
- 8Product Impact and Patient Risk Assessment
- 9Laboratory Deviations and OOS Investigations
Root Cause Investigation
Build advanced investigation competency through structured planning, evidence collection, causal analysis, human-factors evaluation, and defensible technical reporting.
- 10Investigation Strategy and Team Formation
- 11Evidence Collection and Sample Preservation
- 12Laboratory Controls and Batch Record Integrity
- 13Interviews and Process Reconstruction
- 14Root Cause Analysis Tools and Selection
- 15Human Factors and Systemic Root Causes
- 16Investigation Conclusions and Technical Reports
CAPA Development and Effectiveness
Translate investigation conclusions into targeted corrective and preventive actions, manage implementation through controlled quality processes, and verify sustained effectiveness.
- 17Correction and CAPA Strategy Selection
- 18CAPA Documentation and Measurable Deliverables
- 19CAPA Implementation and Change Integration
- 20CAPA Effectiveness Criteria and Verification
- 21CAPA Effectiveness Study Design
- 22CAPA Failure and Recurrence Management
- 23CAPA Closure and Evidence Review
Quality Risk and Change Control
Apply risk-based decision-making, structured assessment tools, controlled change processes, and quality metrics to prevent recurrence and maintain a sustained state of control.
- 24ICH Q9(R1) Risk Assessment
- 25GMP Change Control and Validation Impact
- 26Quality Metrics and Risk-Based Prioritization
- 27Self-Inspection and Management Review
Regulatory Inspection Readiness
Prepare personnel, records, facilities, and quality-system evidence for FDA and EU GMP inspections, develop defensible Form 483 responses, and demonstrate complete remediation through an integrated capstone.
- 28Inspection Readiness and Documentation Control
- 29FDA and EU Inspection Conduct
- 30Investigation Evidence and Inspection Narratives
- 31FDA Form 483 Response Development
- 32Regulatory Commitments and Remediation
- 33EU GMP Inspection and Sample Readiness
- 34EU GMP Inspection Simulation
- 35Deviation Investigation and CAPA Capstone
- 36Mock Inspection and Form 483 Simulation